Nov 17, 2021

Quality Assurance Specialist

$60,000 - $80,000 yearly
  • InfuSystem, Inc.
  • Lenexa, KS, USA
Full-Time Health Care

Job Description

InfuSystem is a growing healthcare service provider, who provides durable medical equipment (DME)  and services to patients in hospitals, clinics, ambulatory surgery centers, and other major service centers.  We provide direct payer rentals, pump and consumable sales, and biomedical services and repair, serving all 50 states and Canada.  Headquartered in Rochester Hills, Michigan, we have Centers of Excellence in Kansas, California, Massachusetts, and Ontario, Canada.

As a leader in our field, our mission is to provide quality infusion services to patients and medical practices, including a 24‐hour clinical support hotline. Our team effort provides product management and clinical support to enhance the lives of our patients and the communities we serve. Service is always our highest priority; keeping the patients’ health & safety at the center of everything we do.

 

*** This position is based out of our Lenexa, KS location***


SUMMARY:
The Quality Assurance Specialist will assure the company remains compliant with regulations and internal quality procedures/policies, and supports activities consistent with company quality objectives and company mission statement. This role supports the Quality Management System in all daily quality activities as detailed below.

IN THIS ROLE, THE IDEAL CANDIDATE WILL:

  • Lead and monitor all internal auditing activities as required by the Quality Management System. This includes conducting opening and closing meetings, preparing and presenting final audit reports, and documenting findings in QA software.  Maintains annual audit schedule and assures completion of the schedule annually.  Assures all findings are addressed within the 30 days and sees all findings through to completion including follow up.  May assist on other audits, as assigned.
  • Conducts training on Quality documents where Quality department is a trainer. Reports on delinquent trainings in quality training and works with leaders to accomplish compliance.
  • Facilitates quarterly meetings:
    • Material Review Board meeting maintains meeting minutes and follows up on progress and dispositions for all sites.
    • Quality Review and Performance Improvement in collaboration with the Product Complaint Analyst and Compliance and Quality Specialist. Assures meeting minutes and follow up items are completed in a timely manner.
  • Manages Corrective Actions (CA), facilitates Root Cause Analysis activities, assures corrective actions are appropriate and completed in a timely manner.
  • Gathers and aggregates data for monthly quality objectives. Monitors trends and seeks out corrective actions when goals are not reached.
  • Serves as management representative for external audits including ISO, Health Canada, FDA, and Boards of Pharmacy.
  • Manages recall notifications and communicates to recall distribution list and publishes to intranet. Facilitates all recall committee meetings.  Oversees recalls through completion including overseeing remediation activities.  Monitors latest recalls by following FDA and HC publications.
  • Maintains business licenses for DME business. Remains vigilant on any changes to regulations in licensing that could have an impact on InfuSystem.

 

SUPERVISORY RESPONSIBILITIES: 
This position has no supervisory responsibilities

THE IDEAL CANDIDATE WILL HAVE THE FOLLOWING QUALIFICATIONS:

  • Bachelor’s Degree or technical school preferred
  • Minimum 3 years of previous experience operating under a Quality Management System
  • Experience in healthcare accreditation process preferred, but not required
  • Prior experience within Quality Assurance or Quality Control required
  • Analytical - Synthesize complex or diverse information; collect and research data; use intuition and experience to complement data
  • Design - use feedback to suggest modifications/improvements to processes. Demonstrate attention to detail
  • Problem Solving - gathers and analyzes information skillfully, and works well in group problem solving situations
  • Technical Skills - Pursues training and development opportunities to support knowledge of quality and other regulatory agencies, and strives to continuously build knowledge and skills
  • Teamwork - Contribute to building a positive team spirit and model teamwork to members
  • Strategic Thinking – Follow Management’s strategy to achieve organizational goals while maintaining compliance, and adapts to changing conditions
  • Motivation - Set and achieve challenging goals in agreement with Management



TRAVEL:
Must be able to travel approximately 10%, with overnights

 

PERSONAL AND PROFESSIONAL ATTRIBUTES:
The ideal candidate must be a rigorous analytical thinker and problem solver with the following professional attributes:

  • Strong work ethic
  • Sound judgment
  • Proven written and verbal communication skills
  • Natural curiosity to pursue issues and increase expertise
  • Pursue and design innovative analytical performance metrics
  • The courage to promote and defend ideas and analyses
  • Passionate about InfuSystem and serving customers and patients
  • Strives to make an impact on improving our business processes and results
  • Exemplary honesty and integrity
  • Ability to collaborate effectively and work selflessly as part of a team

 

PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


COMPREHENSIVE BENEFIT PACKAGE:
At InfuSystem, we give our employees the tools to succeed both on and off the job. Our generous benefits package provides comprehensive coverage to help you protect your health and earning power and prepare for the future. In addition, we offer perks and programs that help you grow in your career and make InfuSystem a great place to work!    

  • Health plan options that include an employer contribution
  • Health Savings Account
  • Healthcare and Dependent Care Flexible Spending Accounts (FSA)
  • Dental and Vision premiums covered by InfuSystem
  • 401(k) with a specified Company Match
  • Life Insurance, STD & LTD
  • Employee Stock Purchase Program
  • Tuition Assistance
  • Generous Paid Time Off plan
  • Paid Parental Leave
  • Employee Assistance Program
  • Competitive Pay
  • Direct Deposit
  • Employee Referral Bonus

States

KS

Security Clearance

NO Security Clearance

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